Introducing DermaSensor: The FDA-Approved Skin Cancer Detecting Device
GRG Health Newsletter - January 2024
With AI-powered spectroscopic technology, the new portable medical equipment assists medical professionals in diagnosing three prevalent forms of skin cancer.
DermaSensor is an AI-powered prescription device approved by the U.S. Food and Drug Administration (FDA) on Friday, January 12. PCPs can use DermaSensor to help them identify problematic skin lesions, including melanoma, basal cell carcinoma, or squamous cell carcinoma. According to the FDA, physicians should not utilize the gadget to confirm a skin cancer diagnosis. Rather, the medical professional should recommend the patient see a dermatologist if DermaSensor suggests a lesion might be malignant.
The FDA mandates post-market performance testing of DermoSensor devices to ensure their effectiveness in individuals with lower skin cancer risk but more poor outcomes, such as Black individuals.
How does DermaSensor work?
According to the company's website, the device takes five spectral records when a medical professional place it on a suspected skin lesion. After analyzing the data, an algorithm produces one of two outcomes.
A "Monitor" result indicates no need for more evaluation then, while a "Investigate Further" result indicates the patient should have the lesion examined by a dermatologist.
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The gadget emits light when it comes into contact with skin, and it records the light wavelengths reflecting off the cellular structures beneath the skin's surface. After that, it makes use of an algorithm to examine the reflected light and find any instances of skin cancer. Skin cancer is the most common cancer worldwide, and in the United States, its most deadly form, melanoma, claims the lives of about 9,000 individuals annually.
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What FDA's approval is based on?
The company says the FDA's approval is based on a Mayo Clinic study involving over 1,000 participants. The findings showed the device had a sensitivity of 96% across all 224 skin cancers, and a negative result had a 97% chance of being benign. A companion study revealed that the DermaSensor system reduced the number of missed skin cancer diagnoses by 50%.
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